FDAClass IIIJune 22, 2016

Librax recall: Impurity Out of Spec

Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant…

Why was Librax recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19

Product
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant…
Recalling firm
Valeant Pharmaceuticals North America LLC
Quantity
6,321 bottles
Distribution
Nationwide and Puerto Rico
Recall date
June 22, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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